Callan v. GD Searle & Co.

• Decision Date: 27 March 1989
• Docket Number: Civ. No. B-87-1312.
• Citation: 709 F. Supp. 662
• Court: U.S. District Court — District of Maryland
• Parties: Virginia Ann CALLAN, Charles Oliver Richardson, III v. G.D. SEARLE & COMPANY, Searle Pharmaceuticals, Inc.

709 F. Supp. 662

Virginia Ann CALLAN, Charles Oliver Richardson, III v. G.D. SEARLE & COMPANY, Searle Pharmaceuticals, Inc.

Civ. No. B-87-1312.

United States District Court, D. Maryland.

March 27, 1989.

H. Robert Erwin, Jr., Pretl & Erwin, Baltimore, Md., for plaintiffs.

Paul F. Strain, James L. Shea, Elizabeth C. Honeywell, W. Warren Hamel, Baltimore, Md., for defendants.

WALTER E. BLACK, Jr., District Judge.

Pending before the Court is defendants' Motion for Summary Judgment based upon federal preemption of state tort law. After careful review, the Court denies the motion.

Under Rule 56 of the Federal Rules of Civil Procedure, a motion for summary judgment shall be granted if there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 250, 106 S.Ct. 2505, 2511, 91 L.Ed.2d 202 (1986).

The underlying facts are not in dispute in this motion but are summarized briefly to put the legal issues in context. Plaintiff¹ alleges that her use of a Cu-7 ("Copper 7") intrauterine device (IUD), which was developed, manufactured and promoted by defendants², caused her to suffer pelvic inflammatory disease, severe damage to her reproductive organs, and infertility. As a result of these injuries, plaintiffs also claim loss of consortium. Plaintiff alleges that she bought and was inserted with a copper-based IUD on three separate occasions for the purposes of temporary contraception and that each IUD was developed, manufactured, and promoted by one or both defendants. Plaintiff claims she was never informed of the risk of pelvic inflammatory disease or infertility. The first two IUDs, a Cu-T and a Cu-7, were inserted and removed at three-year intervals according to the manufacturer's instructions. On the third occasion in 1979, plaintiff was inserted with a Cu-7 IUD, and a year later began experiencing heavier and longer menstrual periods with severe cramping. That same year, the Cu-7 string withdrew into her uterus and, after the physician located the IUD by ultrasound, plaintiff requested that it be removed. Plaintiff eventually discontinued use of contraception in order to become pregnant. In 1984, plaintiff was hospitalized and diagnosed as having probable chronic pelvic inflammatory disease. In subsequent years, she was treated for injuries to her reproductive organs. Plaintiffs' complaint comprises theories of liability based on negligence, strict liability, fraudulent misrepresentation and breach of warranty.

It is the position of defendants that state tort law liability is preempted by the Federal Food, Drug and Cosmetic Act of 1938 (FDCA), 21 U.S.C. §§ 301, et seq., and by the 1976 Medical Device Amendments to the FDCA, 21 U.S.C. §§ 360c, et seq.

The Court directs its attention first to the FDCA. Defendants assert that because the Food and Drug Administration (FDA) approved the Cu-7 IUD for marketing in 1974 as a prescription drug under the FDCA and approved the warning label to accompany the product, state tort law is effectively preempted. In particular, defendants note that the FDA conducted clinical trials relating to pelvic inflammatory disease before approving the Cu-7 IUD, and insist that it would be impermissible for a jury to determine that the product was unreasonably dangerous, that it was unreasonable to place the product on the market, or that the warning was inadequate.

In Abbot by Abbot v. American Cyanamid Co., 844 F.2d 1108 (4th Cir.), cert. denied, ___ U.S. ___, 109 S.Ct. 260, 102 L.Ed.2d 248 (1988), the Fourth Circuit considered whether the Federal Food, Drug and Cosmetic Act preempted state common law liability for defective design or failure to warn against a manufacturer of a vaccine, and concluded that "Congress did not intend, either expressly or impliedly, to preempt state law," Id. at 1111. In that decision, the Court succinctly stated the law on federal preemption as follows:

The doctrine of federal preemption of state law arises under the supremacy clause of the United States Constitution, art. VI, cl. 2. Preemption occurs in any of three manners: (1) Congress may pass a statute that by its express terms preempts state law, (2) Congress, though not expressly so stating, may imply that it is preempting state law by occupation of an entire field of regulation, so that no room is left for supplementary state regulation, (3) Congress may speak neither expressly nor impliedly of preemption, nonetheless state law is preempted to the extent it actually conflicts with federal law; such a conflict occurs when (a) compliance with both state and federal law is impossible or (b) when state law stands as an impediment to a federal purpose.

Id. Defendants concede that the Abbot decision holds that in enacting the FDCA, Congress did not expressly preempt state tort law and did not impliedly preempt state law by occupying the entire field of regulation. Defendants' principal argument has been that the Fourth Circuit in Abbot had not decided the question of whether the FDCA actually conflicts with state tort law. The Court disagrees but finds in any case that state tort law is not preempted through an actual conflict with FDA regulation.

In Abbot, the Court specifically rejected defendants' "narrow preemption" argument that national public health purposes would be frustrated by state tort law liability. Id. at 1113-14. Noting the competing goals of product safety, which is enhanced by state tort law, and product availability and use, which can be frustrated by state law, the Court stated that the main issue was whether federal regulations had struck the balance between safety and quantity or merely established minimum safety standards. The Court concluded that as to vaccines, federal regulations promulgated pursuant to the FDCA served only as minimum standards. The Court cited Hillsborough County, Florida v. Automated Medical Laboratories, Inc., 471 U.S. 707, 721, 105 S.Ct. 2371, 2379, 85 L.Ed.2d 714 (1985), where the Supreme Court found that in regulating the collection of blood plasma, neither Congress nor the FDA had struck a particular balance between safety and quantity, but instead had merely established minimum safety standards. In Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293, 1299 (D.Minn.1988), the Court rejected an identical preemption claim involving the Cu-7 IUD and noted the widely held view that FDA regulation of prescription drugs establishes minimum standards both as to design and warning. This Court finds that FDA approval of the design and warnings for the Cu-7 IUD provided minimum standards and thus would not necessarily conflict with a jury determination that the product was unreasonably dangerous, that defendants were unreasonable in marketing the product, or that the warnings were inadequate. Compliance with state and federal law is not impossible. This is particularly true where plaintiffs allege, as they do here, that defendants misrepresented or withheld relevant data concerning the Cu-7 IUD and pelvic inflammatory disease, causing the FDA to base its decisions on erroneous or incomplete information.

Like the Court in Kociemba, this Court is also persuaded by the Supreme Court's ruling in Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984), which held that an award of punitive damages against the manufacturer of plutonium products did not conflict with federal law regulating the nuclear energy industry. The Court found that the tort judgment was not precluded by federal law despite the ruling in Pacific Gas & Electric Co. v. State Energy Resources Conservation & Development Comm'n, 461 U.S. 190, 211-13, 103 S.Ct. 1713, 1726-27, 75 L.Ed.2d 752 (1983), that States are precluded from regulating the safety aspects of nuclear energy. The Court stated:

No doubt there is tension between the conclusion that safety regulation is the exclusive concern of the federal law and the conclusion that a State may nevertheless award damages based on its own law of liability. But as we understand what was done over the years in the legislation concerning nuclear energy, Congress intended to stand by both concepts and to tolerate whatever tension there was between them. We can do no less. It may be that the award of damages based on the state law of negligence or strict liability is regulatory in the sense that a nuclear plant will be threatened with damages liability if it does not conform to state standards, but that regulatory consequence was something that Congress was quite willing to accept.

Id. at 256, 104 S.Ct. at 625. Thus, the Supreme Court in Silkwood made it clear that Congressional intent is important in determining whether federal preemption might exist where there is tension between federal and state law. The Supreme Court found no indication that Congress intended to preclude state tort remedies in the Atomic Energy Act of 1954 as enacted or as amended in 1959. The Court stated: "This silence takes on added significance in light of Congress' failure to provide any federal remedy for persons injured by such conduct. It is difficult to believe that Congress, would, without comment, remove all means of judicial recourse for those injured by illegal conduct." Id. at 251, 104 S.Ct. at 623. FDA regulation of the Cu-7 IUD presents less of a conflict between state and federal law than regulation of nuclear energy by the Nuclear Regulatory Commission; in Abbot, the Court found that an analysis of later vaccine legislation indicated that Congress had assumed that state civil actions were available under the FDCA. 844 F.2d at 1113-14. Furthermore, unlike in Silkwood, Congress in enacting the FDCA did not impliedly preempt state law by occupying the entire field of regulation in terms of product safety. And finally, as in Silkwood, Congress failed to provide any federal remedy for persons injured by illegal conduct.

For all of these reasons,...